Answer · confidence: partial
Would a volunteer's family have to sign anything, and do any rules cover them?
Research question: Would a volunteer's family be asked to sign anything, and do any consent rules cover them?
The records do not show that a volunteer's family would be asked to sign anything. The main federal protection for commercial spaceflight participants is the informed-consent regime in 14 C.F.R. § 460.45 1, which requires written consent after disclosure of known hazards and the vehicle's safety record 4. The subpart B research protections cover pregnant women, fetuses and neonates, not general volunteers' families 5, and FDA's consent guidance does not mention volunteers' families 14. Family consent appears in the facts only in narrow cases, such as parents consenting for minors 1821 or for neonates 2, so those rules would not clearly reach a typical volunteer's family. The newest fact is dated September 18, 2026, about a month before October 2026 14.
Checked 2026-10-22. Only documented and supported facts are used.
Dig deeper on this questionSources
[1] supported
The main federal protection for commercial spaceflight participants is the informed-consent regime in 14 C.F.R. § 460.45.
"The principal federal protection for commercial spaceflight participants is therefore the informed-consent regime in 14 C.F.R. § 460.45."Consent Without Data: The Regulatory Gap for Female Commercial Spaceflight Participants Under the FAA’s Informed Consent Regime (2026)
[2] documented
For research involving neonates, the rule requires consent from either parent (or a parent's legally authorized representative if neither parent can consent), except that the father's consent is not needed if the pregnancy resulted from rape or incest.
"Sixth, Sec. 46.205(b)(2) is amended to state that the consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained in accord with the pre-2018 Requirements or the 2018 Requirements, as applicable, except that t"Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations (Health and Human Services Department, 2024-10-24)
[3] supported
AmeriCorps adopted the Common Rule so that research involving human subjects it conducts, supports, or regulates is subject to the Common Rule's ethical principles and procedures, which include obtaining and documenting informed consent.
"The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an IRB, obtaining and documenting informed consent of human subjects, and submitting written assurance of institutional compliance with the Common Rule."Protection of Human Subjects (Corporation for National and Community Service, 2024-10-29)
[4] supported
The informed-consent regime requires disclosure of known hazards, an acknowledgement that unknown hazards exist, disclosure of the vehicle's safety record, an opportunity to ask questions, and written consent.
"ent that unknown hazards exist, disclosure of the vehicle’s safety record, an opportunity to ask questions, and written consent."Consent Without Data: The Regulatory Gap for Female Commercial Spaceflight Participants Under the FAA’s Informed Consent Regime (2026)
[5] supported
The subpart B protections cover pregnant women, human fetuses and neonates involved in research, a category first promulgated in 1975 and not general volunteers' families.
"Subpart B of 45 CFR part 46, ``Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research,'' was first promulgated on August 8, 1975."Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations (Health and Human Services Department, 2024-10-24)
[6] documented
Before the rule, AmeriCorps typically ensured that informed consent of human subjects was properly obtained, and it had IRB review for research run by universities and other partners it supported.
"AmeriCorps' research is therefore already guided by these codes of ethics, and the agency typically engages in practices such as ensuring that informed consent of human subjects is properly obtained and, when supporting research is conducted by universities and other research partners, ensuring that the research is reviewed and approved by an IRB."Protection of Human Subjects (Corporation for National and Community Service, 2024-10-29)
[7] supported
The study's authors recommend that alternatives to the planned procedure be explained to the patient or the next of kin, which suggests family members are expected to take part in consent discussions.
"various alternatives to it must be disseminated to the patient or the next of kin to improve the quality of the informed consent-taking process."How informed is informed consent?—Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal (2023)
[8] documented
The rule is meant to assure prospective and participating human research subjects in AmeriCorps-conducted or supported research that AmeriCorps follows the same ethical and procedural provisions as HHS and 19 other agencies.
"AmeriCorps' adoption of the Common Rule also provides assurance to individuals who are prospective and participating human research subjects for AmeriCorps-conducted or supported research that AmeriCorps abides by the same ethical and procedural provisions that HHS and 19 other agencies do."Protection of Human Subjects (Corporation for National and Community Service, 2024-10-29)
[9] supported
Consent is often taken hastily, minutes before the procedure, when patients are not in the right state of mind to process complex information.
"Taking informed consent from the patients hastily and minutes before the procedure when patients are not in the right state of mind to process complex information has been a major issue"How informed is informed consent?—Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal (2023)
[10] documented
Almost 20% of the case reports evaluated did not comply with journal policies on documenting consent to publish.
"Almost 20% of articles evaluated did not comply with journal policies on documenting consent, and, in an additional 30%, it was not possible to document compliance because journal policies did not require documentation within the manuscript."Patient and family consent for publication: A bibliographic and ethical analysis of recent case reports from a single institution (2025)
[11] documented
The FDA guidance does not establish any rights for any person and is not binding on FDA or the public.
"It does not establish any rights for any person and is not binding on FDA or the public."Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability (Health and Human Services Department, Food and Drug Administration, 2023-08-16)
[12] documented
For an IRB to waive or alter informed consent for minimal risk clinical investigations, the rule requires the IRB to find and document five criteria.
"For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria"Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Health and Human Services Department, Food and Drug Administration, 2023-12-21)
[13] documented
For an additional 30% of the case reports, compliance with consent policies could not be documented because the journals did not require consent to be documented within the manuscript.
"in an additional 30%, it was not possible to document compliance because journal policies did not require documentation within the manuscript."Patient and family consent for publication: A bibliographic and ethical analysis of recent case reports from a single institution (2025)
[14] supported
The guidance is aimed at institutional review boards, clinical investigators, and sponsors in carrying out their informed consent responsibilities, and the notice does not mention volunteers' families.
"intended to assist IRBs, clinical investigators, and sponsors"Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability (Health and Human Services Department, Food and Drug Administration, 2023-08-16)
[15] documented
FDA chose not to require, under the waiver provision, that investigators obtain consent from subjects or their legally authorized representatives (LARs) when feasible.
"FDA is not including a requirement in Sec. 50.22 that the investigator obtain consent from subjects or LARs if feasible"Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Health and Human Services Department, Food and Drug Administration, 2023-12-21)
[16] supported
The document says that the death of a research participant makes obtaining new consent impracticable.
"Seemingly, the death of a research participant renders new consent ‘‘impracticable’’."La recherche internationale en génétique et l’utilisation secondaire des données : entre dissociation et harmonisation (2015)
[17] documented
Waivers or alterations of informed consent are meant only for situations where the investigation cannot practicably be carried out as designed without the waiver or alteration.
"Waivers or alterations of informed consent under Sec. 50.22 are intended for situations where it is impracticable to carry out the clinical investigation, as designed, without the waiver or alteration."Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Health and Human Services Department, Food and Drug Administration, 2023-12-21)
[18] supported
Minors cannot legally consent to research participation, so parental consent is required for them to join a trial.
"Minors cannot consent to research participation by law, requiring parental consent, and participation must be fully voluntary without affecting access to standard care."Ethics of Puberty Blocker Policy: Consent, Evidence, and Clinical Justice (2025)
[19] supported
Research using deceased individuals' data is not directly addressed by the guidelines, but it falls under the third waiver criterion because death makes new consent impracticable.
"Although the particular case of research with deceased individuals’ data is not directly addressed, it would be covered by the third criteria, above, since death makes obtaining new consent impracticable."La recherche internationale en génétique et l’utilisation secondaire des données : entre dissociation et harmonisation (2015)
[20] supported
The emergency research rule (Sec. 50.24) requires IRB approval of consent procedures and a consent document used to obtain consent from a subject or LAR when feasible, which the waiver rule does not mirror.
"that provision requires IRB approval of informed consent procedures and an informed consent document that are to be used to obtain consent from a subject or LAR, when feasible."Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Health and Human Services Department, Food and Drug Administration, 2023-12-21)
[21] supported
Because minors cannot consent to take part in research, their parents must consent on their behalf.
"But they cannot consent to take part in research. parents will have to consent on their behalf."Ethics of Puberty Blocker Policy: Consent, Evidence, and Clinical Justice (2025)
[22] supported
Under CIOMS guidance, an ethics committee may waive some or all elements of informed consent only when the research involves no more than minimal risk and individual informed consent would make the research impracticable.
"A requirement of individual informed consent would make the conduct of the research impracticable[33]."La recherche internationale en génétique et l’utilisation secondaire des données : entre dissociation et harmonisation (2015)